Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006708
Status:
TERMINATED
Last Update Posted:
2013-04-10
First Post:
2000-12-06
Brief Title:
S0019 Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Randomized Phase III Trial of ICE Chemotherapy With or Without Rituximab for the Treatment of Relapsed or Refractory CD20 Expressing Aggressive B-Cell Non-Hodgkins Lymphomas in Patients Not Suitable for High Dose Therapy and PBSCT
Status:
TERMINATED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells It is not yet known whether combination chemotherapy is more effective with or without rituximab for non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without rituximab in treating patients who have relapsed or refractory non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without rituximab in treating patients who have relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Compare the progression-free and overall survival of patients with relapsed or refractory CD20 expressing aggressive B-cell non-Hodgkins lymphoma treated with ifosfamide carboplatin and etoposide with or without rituximab II Compare the unconfirmed response rate of patients treated with these regimens III Determine the toxicity of ifosfamide carboplatin and etoposide with rituximab in these patients
OUTLINE This is a randomized study Patients are stratified according to histology large B-cell vs other and risk group lowlow-intermediate vs high-intermediatehigh Patients are randomized to one of two treatment arms Arm I Patients receive etoposide IV over 1 hour on days 1-3 carboplatin IV over 1 hour on day 2 ifosfamide IV continuously for 24 hours on day 2 and filgrastim G-CSF subcutaneously SC on days 5-12 Treatment continues every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Arm II Patients receive rituximab IV on day 1 etoposide IV over 1 hour on days 2-4 carboplatin IV over 1 hour on day 3 ifosfamide IV continuously for 24 hours on day 3 and G-CSF SC on days 6-13 Patients also receive rituximab IV on day 8 of course 1 Treatment continues every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually for 5 years
PROJECTED ACCRUAL A total of 376 patients 188 per arm will be accrued for this study within 3 years
OUTLINE This is a randomized study Patients are stratified according to histology large B-cell vs other and risk group lowlow-intermediate vs high-intermediatehigh Patients are randomized to one of two treatment arms Arm I Patients receive etoposide IV over 1 hour on days 1-3 carboplatin IV over 1 hour on day 2 ifosfamide IV continuously for 24 hours on day 2 and filgrastim G-CSF subcutaneously SC on days 5-12 Treatment continues every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Arm II Patients receive rituximab IV on day 1 etoposide IV over 1 hour on days 2-4 carboplatin IV over 1 hour on day 3 ifosfamide IV continuously for 24 hours on day 3 and G-CSF SC on days 6-13 Patients also receive rituximab IV on day 8 of course 1 Treatment continues every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually for 5 years
PROJECTED ACCRUAL A total of 376 patients 188 per arm will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S0019 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |